Overcoming Technology Transfer Challenges

Each type of tech transfer project presents its own set of challenges. The key to a successful tech transfer is for the vendor and the contract manufacturer to anticipate the challenges and come up with a game plan for the solutions to potential challenges. Challenges can include, timeline of project deliverables (for ANDA or NDA submission), the amount and quality of documentation from develop site, material variances, custom clearances (where applicable), and the added complexity of fast track or orphan designation compounds.